The NIDDK in collaboration with the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Dietary Supplement (CDS) funded 11 clinical centers and a coordinating site for seven years from 2002 -2009 to investigate phytotherapy for benign prostatic hyperplasia (BPH). University of Colorado Denver (UCD) was selected as one of the 11 clinical centers for this study, known as the Complementary and Alternative Medicine for Urological Symptoms (CAMUS) trial. The CAMUS study team designed a double-blind, placebo-controlled, eighteen-month clinical trial of treatment with single usual dose (320 mg/day), double usual dose (640 mg/day) and triple usual dose (960 mg/day) of saw palmetto (Serenoa repens) to determine the efficacy and safety of Serenoa repens at reducing the lower urinary tract symptoms associated with BPH. A total of 369 men, substantially more than the 350 specified in the protocol, have been randomized into the study and are currently being treated and followed at the 11 clinical centers. UCD randomized 30 men to either Serenoa repens or placebo. Of the 30 men who were randomized, 29 are in active treatment and follow-up. We anticipate that all will complete 18 months of follow-up as per protocol, however, the protocol-specified treatment period for the last participants randomized extends beyond the current funding period, which ends March 31, 2010. This proposal is for continued funding for the period July 1, 2010 to June 30, 2011 to allow the CAMUS clinical trial to complete its activities. Funding for this period is needed so that participants will have time to complete the full protocol-specified treatment period, and so that clinical centers can participate in data clean-up, final data analyses, and publication activities. PUBLIC HEALTH RELEVANCE: This Study is being conducted because, despite worldwide use of phytotherapies, the effectiveness and side effects of these over-the-counter dietary supplements for men with benign prostatic hyperplasia are unclear. If Saw palmetto, one of the most commonly used supplements, is effective at reducing lower urinary tract symptoms, it might be preferred by many men because of its "natural therapy" appeal, and its lower cost, relative to prescription medications for BPH.